510(k) K252637

Community Containers (Flap and Daisy) by Keter Canada, Inc. — Product Code MMK

K252637 is an FDA 510(k) premarket notification submitted by Keter Canada, Inc. for the device "Community Containers (Flap and Daisy)". The FDA issued a decision of Substantially Equivalent on October 14, 2025. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2025
Date Received
August 20, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Sharps
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type